BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1024879-2017-00448

    MDR report key: 7076543 · Received December 1, 2017

    Report

    Report Number
    1024879-2017-00448
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    February 12, 2016
    Report Date
    October 23, 2017
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A PHOTO WAS PROVIDED BY CUSTOMER BUT UNABLE TO VIEW DEFECT. A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5140679. UNCONFIRMED. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY COMPLAINT FROM HK BAPTIST HOSPITAL LAB THAT THE USER HAD BLOOD SPILLAGE DURING BLOOD DRAWING WHEN CHANGING THE BLOOD CULTURE BOTTLE (GREINERI'S PRODUCTS) FROM A 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 7 IN. TUBING AND LUER ADAPTER. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other